Novartis Loses Bid to Halt Generic Drug Launch

A U.S. judge ruled against Novartis, allowing MSN Pharmaceuticals to launch a generic version of Entresto prior to its patent expiry next year. Novartis plans to appeal the decision, which could impact the market for its heart-failure drug that generated over $7.8 billion last year.

In a significant legal setback for Novartis, a Delaware federal judge has ruled that MSN Pharmaceuticals can proceed with the launch of a generic heart-failure drug, Entresto, ahead of its patent expiration in November 2026. The decision was handed down by U.S. District Judge Richard Andrews, rejecting Novartis' claims of patent infringement.

This ruling comes after Novartis initially secured a halt on MSN's launch from the U.S. Court of Appeals for the Federal Circuit back in January. Despite the setback, Novartis intends to appeal, highlighting its disappointment in the ruling. The potential approval and subsequent launch of the generic could severely impact Entresto's market share, with the drug having earned the company more than $7.8 billion in global revenues last year.

Novartis' financial performance reflected immediate investor concerns, as its stock dropped more than 2% on the news. Meanwhile, MSN Pharmaceuticals, based in India, remains poised to receive FDA approval, potentially as soon as mid-July, positioning it to capitalize on the opening market.

(With inputs from agencies.)